This client that we are working with are currently expanding several teams across the business, including the documentation aspect, and as a result are seeking a new Documentation Specialist to come in on a full-time capacity.

The main responsibilities are laid out below:

• Support the management of the Electronic Documentation System and training system, providing training as required.
• Revision Control of BOM's, engineering drawings, work instructions within ERP.
• Process and work on changes within the QMS from a QMS and engineering standpoint.
• Provide audit support during on-site audits and inspections.
• Coordinate and collaborate with stakeholders to establish and maintain document templates, formatting standards and version control systems.
• Oversee several aspects of the controlled documents and create, review, approve and revise additional documents including standard operating procedures (SOP's).

The preferred background and experience required for the role is included below:

• 5 years' of medical device/life sciences industry experience, ideally in a 13485, 9001 environment.
• Experience across eQMS with a particular focus on document control and training.
• Strong knowledge of GDP and GMP practice and principles.
• Associate's degree required, bachelors preferred.